ITU-T H 845 2-2015 Conformance of ITU-T H 810 personal health devices PAN LAN TAN interface Part 5B Glucose meter Agent (Study Group 16)《ITU-T H 810的个人健康设备的一致性 PAN LAN TAN接口部分5B 血糖.pdf

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1、 I n t e r n a t i o n a l T e l e c o m m u n i c a t i o n U n i o n ITU-T H.845.2 TELECOMMUNICATION STANDARDIZATION SECTOR OF ITU (01/2015) SERIES H: AUDIOVISUAL AND MULTIMEDIA SYSTEMS E-health multimedia services and applications Interoperability compliance testing of personal health systems (HR

2、N, PAN, LAN, TAN and WAN) Conformance of ITU-T H.810 personal health devices: PAN/LAN/TAN interface Part 5B: Glucose meter: Agent Recommendation ITU-T H.845.2 ITU-T H-SERIES RECOMMENDATIONS AUDIOVISUAL AND MULTIMEDIA SYSTEMS CHARACTERISTICS OF VISUAL TELEPHONE SYSTEMS H.100H.199 INFRASTRUCTURE OF AU

3、DIOVISUAL SERVICES General H.200H.219 Transmission multiplexing and synchronization H.220H.229 Systems aspects H.230H.239 Communication procedures H.240H.259 Coding of moving video H.260H.279 Related systems aspects H.280H.299 Systems and terminal equipment for audiovisual services H.300H.349 Direct

4、ory services architecture for audiovisual and multimedia services H.350H.359 Quality of service architecture for audiovisual and multimedia services H.360H.369 Telepresence H.420H.429 Supplementary services for multimedia H.450H.499 MOBILITY AND COLLABORATION PROCEDURES Overview of Mobility and Coll

5、aboration, definitions, protocols and procedures H.500H.509 Mobility for H-Series multimedia systems and services H.510H.519 Mobile multimedia collaboration applications and services H.520H.529 Security for mobile multimedia systems and services H.530H.539 Security for mobile multimedia collaboratio

6、n applications and services H.540H.549 Mobility interworking procedures H.550H.559 Mobile multimedia collaboration inter-working procedures H.560H.569 BROADBAND, TRIPLE-PLAY AND ADVANCED MULTIMEDIA SERVICES Broadband multimedia services over VDSL H.610H.619 Advanced multimedia services and applicati

7、ons H.620H.629 Ubiquitous sensor network applications and Internet of Things H.640H.649 IPTV MULTIMEDIA SERVICES AND APPLICATIONS FOR IPTV General aspects H.700H.719 IPTV terminal devices H.720H.729 IPTV middleware H.730H.739 IPTV application event handling H.740H.749 IPTV metadata H.750H.759 IPTV m

8、ultimedia application frameworks H.760H.769 IPTV service discovery up to consumption H.770H.779 Digital Signage H.780H.789 E-HEALTH MULTIMEDIA SERVICES AND APPLICATIONS Interoperability compliance testing of personal health systems (HRN, PAN, LAN, TAN and WAN) H.820H.859 Multimedia e-health data exc

9、hange services H.860H.869 For further details, please refer to the list of ITU-T Recommendations. Rec. ITU-T H.845.2 (01/2015) i Recommendation ITU-T H.845.2 Conformance of ITU-T H.810 personal health devices: PAN/LAN/TAN interface Part 5B: Glucose meter: Agent Summary Recommendation ITU-T H.845.2 i

10、s a transposition of Continua Test Tool DG2013, Test Suite Structure Part 5B: Device Specializations. Agent (Glucose Meter) (Version 1.4, 2014-01-24), that was developed by the Continua Health Alliance. A number of versions of this specification existed before transposition. This Recommendation incl

11、udes an electronic attachment with the protocol implementation conformance statements (PICS) and the protocol implementation extra information for testing (PIXIT) required for the implementation of Annex A. History Edition Recommendation Approval Study Group Unique ID* 1.0 ITU-T H.845.2 2015-01-13 1

12、6 11.1002/1000/12263 _ * To access the Recommendation, type the URL http:/handle.itu.int/ in the address field of your web browser, followed by the Recommendations unique ID. For example, http:/handle.itu.int/11.1002/1000/11830-en. ii Rec. ITU-T H.845.2 (01/2015) FOREWORD The International Telecommu

13、nication Union (ITU) is the United Nations specialized agency in the field of telecommunications, information and communication technologies (ICTs). The ITU Telecommunication Standardization Sector (ITU-T) is a permanent organ of ITU. ITU-T is responsible for studying technical, operating and tariff

14、 questions and issuing Recommendations on them with a view to standardizing telecommunications on a worldwide basis. The World Telecommunication Standardization Assembly (WTSA), which meets every four years, establishes the topics for study by the ITU-T study groups which, in turn, produce Recommend

15、ations on these topics. The approval of ITU-T Recommendations is covered by the procedure laid down in WTSA Resolution 1. In some areas of information technology which fall within ITU-Ts purview, the necessary standards are prepared on a collaborative basis with ISO and IEC. NOTE In this Recommendat

16、ion, the expression “Administration“ is used for conciseness to indicate both a telecommunication administration and a recognized operating agency. Compliance with this Recommendation is voluntary. However, the Recommendation may contain certain mandatory provisions (to ensure, e.g., interoperabilit

17、y or applicability) and compliance with the Recommendation is achieved when all of these mandatory provisions are met. The words “shall“ or some other obligatory language such as “must“ and the negative equivalents are used to express requirements. The use of such words does not suggest that complia

18、nce with the Recommendation is required of any party. INTELLECTUAL PROPERTY RIGHTSITU draws attention to the possibility that the practice or implementation of this Recommendation may involve the use of a claimed Intellectual Property Right. ITU takes no position concerning the evidence, validity or

19、 applicability of claimed Intellectual Property Rights, whether asserted by ITU members or others outside of the Recommendation development process. As of the date of approval of this Recommendation, ITU had not received notice of intellectual property, protected by patents, which may be required to

20、 implement this Recommendation. However, implementers are cautioned that this may not represent the latest information and are therefore strongly urged to consult the TSB patent database at http:/www.itu.int/ITU-T/ipr/. ITU 2015 All rights reserved. No part of this publication may be reproduced, by

21、any means whatsoever, without the prior written permission of ITU. Rec. ITU-T H.845.2 (01/2015) iii Table of Contents Page 1 Scope . 1 2 References . 2 3 Definitions 2 3.1 Terms defined elsewhere 2 3.2 Terms defined in this Recommendation . 2 4 Abbreviations and acronyms 2 5 Conventions 3 6 Test sui

22、te structure (TSS) . 4 7 Electronic attachment . 6 Annex A Test purposes (TPs) . 7 A.1 TP definition conventions . 7 A.2 Subgroup 1.3.2: Glucose meter (GL) . 8 Bibliography. 57 Electronic attachment: Protocol implementation conformance statements (PICS) and protocol implementation extra information

23、for testing (PIXIT) required for the implementation of Annex A. iv Rec. ITU-T H.845.2 (01/2015) Introduction This Recommendation is a transposition of Continua Test Tool DG2013, Test Suite Structure Part 5B: Device Specializations. Agent (Glucose meter) (Version 1.4, 2014-01-24), that was developed

24、by the Continua Health Alliance. A number of versions of this specification existed before transposition and these can be found in the table below. Version Date Revision history 1.2 2012-10-05 Initial release for Test Tool DG2011. This is the same version as “TSS users of this Recommendation are the

25、refore encouraged to investigate the possibility of applying the most recent edition of the Recommendations and other references listed below. A list of the currently valid ITU-T Recommendations is regularly published. The reference to a document within this Recommendation does not give it, as a sta

26、nd-alone document, the status of a Recommendation. ITU-T H.810 Recommendation ITU-T H.810 (2013), Interoperability design guidelines for personal health systems. IEEE 11073-10417 IEEE 11073-10417-2011, Health informatics Personal health device communication Part 10417: Device specialization Glucose

27、meter. ISO/IEEE 11073-20601A ISO/IEEE 11073-20601:2010, Health informatics Personal health device communication Part 20601: Application profile Optimized exchange protocol, including ISO/IEEE 11073-20601:2010 Amd 1:2015. with ISO/IEEE 11073-104xx ISO/IEEE 11073-104xx (in force), Health informatics P

28、ersonal health device communication Device specialization. NOTE This is shorthand used to refer to the collection of device specialization standards that utilize ISO/IEEE 11073-20601A, where xx can be any number from 01 to 99, inclusive. 3 Definitions 3.1 Terms defined elsewhere This Recommendation

29、uses the following terms defined elsewhere: 3.1.1 agent ISO/IEEE 11073-20601A: A node that collects and transmits personal health data to an associated manager. 3.1.2 manager ISO/IEEE 11073-20601A: A node receiving data from one or more agent systems. Some examples of managers include a cellular pho

30、ne, health appliance, set top box, or a computer system. 3.2 Terms defined in this Recommendation None. 4 Abbreviations and acronyms This Recommendation uses the following abbreviations and acronyms: ATS Abstract Test Suite DUT Device Under Test CDG Continua Design Guidelines GUI Graphical User Inte

31、rface Rec. ITU-T H.845.2 (01/2015) 3 INR International Normalized Ratio IUT Implementation Under Test MDS Medical Device System NFC Near Field Communication PAN Personal Area Network PCT Protocol Conformance Testing PCO Point of Control and Observation PHD Personal Healthcare Device PHDC Personal He

32、althcare Device Class PHM Personal Health Manager PICS Protocol Implementation Conformance Statement PIXIT Protocol Implementation extra Information for Testing SDP Service Discovery Protocol SOAP Simple Object Access Protocol TCRL Test Case Reference List TCWG Test and Certification Working Group T

33、P Test Purpose TSS Test Suite Structure USB Universal Serial Bus WDM Windows Driver Model 5 Conventions The key words “SHALL“, “SHALL NOT“, “SHOULD“, “SHOULD NOT“, “MAY“, “MAY NOT“ in this document are to be interpreted as in b-ETSI SR 001 262. SHALL is equivalent to must or it is required to. SHALL

34、 NOT is equivalent to must not or it is not allowed. SHOULD is equivalent to it is recommended to. SHOULD NOT is equivalent to it is not recommended to. MAY is equivalent to is permitted. MAY NOT is equivalent to it is not required that. NOTE The above-mentioned key words are capitalized for illustr

35、ative purposes only and they do not appear capitalized within this Recommendation. Reference is made in the ITU-T H.800-series of Recommendations to different versions of the Continua Design Guidelines (CDG) by a specific designation. The list of terms that may be used in this Recommendation is prov

36、ided in Table 1. 4 Rec. ITU-T H.845.2 (01/2015) Table 1 List of designations associated with the various versions of the CDG CDG name Transposed as Version Description Designation 2013 plus errata ITU-T H.810 4.1 CDG 2013 plus errata noting all ratified bugs. 2013 4.0 Release 2013 of the CDG includi

37、ng maintenance updates of CDG 2012 and additional guidelines that cover new functionalities. Endorphin 2012 plus errata 3.1 CDG 2012 plus errata noting all ratified bugs b-CDG 2012. 2012 3.0 Release 2012 of the CDG including maintenance updates of CDG 2011 and additional guidelines that cover new fu

38、nctionalities. Catalyst 2011 plus errata 2.1 CDG 2011 integrated with identified errata. 2011 2.0 Release 2011 of the CDG including maintenance updates of CDG 2010 and additional guidelines that cover new functionalities b-CDG 2011. Adrenaline 2010 plus errata 1.6 CDG 2010 integrated with identified

39、 errata - 2010 1.5 Release 2010 of the CDG with maintenance updates of CDG Version 1 and additional guidelines that cover new functionalities b-CDG 2010. 1.5 1.0 1.0 First released version of the CDG b-CDG 1.0. 6 Test suite structure (TSS) The test purposes (TPs) for the PAN/LAN/TAN interface have b

40、een divided into the main subgroups specified below. Annex A describes the TPs for subgroup 1.3.2: (shown in bold). Group 1: Agent (AG) Group 1.1: Transport (TR) Subgroup 1.1.1: Design guidelines: Common (DGC) Subgroup 1.1.2: USB design guidelines (UDG) Subgroup 1.1.3: Bluetooth design guidelines (B

41、DG) Subgroup 1.1.4: Pulse oximeter design guidelines (PODG) Subgroup 1.1.5: Cardiovascular design guidelines (CVDG) Subgroup 1.1.6: Activity hub design guidelines (HUBDG) Subgroup 1.1.7: ZigBee design guidelines (ZDG) Subgroup 1.1.8: Glucose meter design guidelines (GLDG) Subgroup 1.1.9: Bluetooth l

42、ow energy design guidelines (BLEDG) Subgroup 1.1.10: Basic electrocardiograph design guidelines (ECGDG) Subgroup 1.1.11: NFC design guidelines (NDG) Group 1.2: Optimized exchange protocol (OXP) Subgroup 1.2.1: PHD domain information model (DIM) Rec. ITU-T H.845.2 (01/2015) 5 Subgroup 1.2.2: PHD serv

43、ice model (SER) Subgroup 1.2.3: PHD communication model (COM) Group 1.3: Devices class specializations (CLASS) Subgroup 1.3.1: Weighing scales (WEG) Subgroup 1.3.2: Glucose meter (GL) Subgroup 1.3.3: Pulse oximeter (PO) Subgroup 1.3.4: Blood pressure monitor (BPM) Subgroup 1.3.5: Thermometer (TH) Su

44、bgroup 1.3.6: Cardiovascular (CV) Subgroup 1.3.7: Strength (ST) Subgroup 1.3.8: Activity hub (HUB) Subgroup 1.3.9: Adherence monitor (AM) Subgroup 1.3.10: Insulin pump (IP) (Future development) Subgroup 1.3.11: Peak flow (PF) Subgroup 1.3.12: Body composition analyser (BCA) Subgroup 1.3.13: Basic el

45、ectrocardiograph (ECG) Subgroup 1.3.14: International normalized ratio (INR) Group 1.4: Personal health device transcoding whitepaper (PHDTW) Subgroup 1.4.1: Whitepaper general requirements (GEN) Subgroup 1.4.2: Whitepaper thermometer requirements (TH) Subgroup 1.4.3: Whitepaper blood pressure requi

46、rements (BPM) Subgroup 1.4.4: Whitepaper heart rate requirements (HR) Subgroup 1.4.5: Whitepaper glucose meter requirements (GL) Group 2: Manager (MAN) Group 2.1: Transport (TR) Subgroup 2.1.1: Design guidelines: Common (DGC) Subgroup 2.1.2: USB design guidelines (UDG) Subgroup 2.1.3: Bluetooth desi

47、gn guidelines (BDG) Subgroup 2.1.4: Cardiovascular design guidelines (CVDG) Subgroup 2.1.5: Activity hub design guidelines (HUBDG) Subgroup 2.1.6: ZigBee design guidelines (ZDG) Subgroup 2.1.7: Bluetooth low energy design guidelines (BLEDG) Subgroup 2.1.8: NFC design guidelines (NDG) Group 2.2: 2060

48、1: Optimized exchange protocol (OXP) Subgroup 2.2.1: General (GEN) Subgroup 2.2.2: PHD domain information model (DIM) Subgroup 2.2.3: PHD service model (SER) Subgroup 2.2.4: PHD communication model (COM) Group 2.3: Devices class specializations (CLASS) Subgroup 2.3.1: Weighing scales (WEG) Subgroup

49、2.3.2: Glucose meter (GL) 6 Rec. ITU-T H.845.2 (01/2015) Subgroup 2.3.3: Pulse oximeter (PO) Subgroup 2.3.4: Blood pressure monitor (BPM) Subgroup 2.3.5: Thermometer (TH) Subgroup 2.3.6: Cardiovascular (CV) Subgroup 2.3.7: Strength (ST) Subgroup 2.3.8: Activity hub (HUB) Subgroup 2.3.9: Adherence monitor (A

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